Specialist Pharmaceutical Quality Systems
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Job Location:
Rockville, MD - USA
Monthly Salary:
Not Disclosed
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
SpecialistPharmaceuticalQuality Systems
Summary:
ThePharmaceuticalQuality SystemsSpecialistenables effective adoption integration and compliance of digital tools acrossQuality Control (QC) cell and gene therapy(CGT)laboratory operations. The role spans system onboarding stakeholder engagement training change managementandissue resolution.Primary systems include1Lab GQCLIMSandMODAand workflow tools such asBusinessmap.
As part ofLaboratoryManagement andStability (LMS) team the role supports sharedcoreresponsibilities such as stability program coordinationsample flow oversightinventory management and the management of OOT/OOS deviations CAPAs and continuous improvementinitiatives.
Key Responsibilities:
Digital Systems Integration: Lead onboarding and configuration of laboratory digital tools across QC processes ensuring workflows templates roles and access align with operational needs and controlled documentation.
Stakeholder Collaboration: Act asliaisonamong laboratory staff IT QA and project leadership to gather requirements address concerns align scope and communicate status and decisions.
Training & Documentation: Develop and deliver user-focused training SOPs quick reference guides and controlled templates; conduct readiness assessments and providepostgolivesupport.
Issue Resolution & Enhancements: Troubleshoot system onboarding and usage challenges; coordinate incident triage and enhancement delivery with technical teams;maintainissue/change logs and user feedback loops.
Data Integrity & Compliance: EnsureGxPaligned configuration and use across systems; uphold 21 CFR Part 11/Annex 11 controls audit trailsrole-basedaccessvalidatedstates and traceability to URS/FRS/test scripts.
LMS Core Operations Support:Support sample flow oversight across QC CGT labs;assistwith investigations for OOT OOS deviations and CAPAs; contribute tostability program; andmaintaininventory management processes including Kanban room controls min/max levels andtimelyreplenishment to sustain compliant operation.
Audit & Inspection Support: Prepare evidence packages (training records configuration summaries validation status change histories) andparticipatein internal/external audits and inspections.
MinimumQualifications:
Associates Degreewith 3years experienceORBachelors inLife Sciences Chemistry or related fieldand one yearexperienceimplementingoradministeringdigital laboratory systemsin GMP environments
Knowledge ofGMP/GxP21 CFR Part 11/Annex 11 andALCOA
Knowledge of1Lab GQCLIMS MODAandBusiness map
Demonstrated ability to design and deliver training author SOPs and lead change management for system rollouts
Excellent stakeholder engagement communication and issue management; comfort withcross-functionalcoordination
The annual base pay for this position ranges from $82223 to$123334. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility toparticipatein our equity-based long-term incentive program (salaried roles) to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coveragein accordance withthe terms and conditions of the applicable plans.Additionaldetails of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.
Date Posted
08-Dec-2025Closing Date
14-Dec-2025Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.
Required Experience:
IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
